Zapalign Inc. (foreign exporter, Anyang-si Gyeonggi, KR): 20 new FDA device listings, incl. agent, tooth bonding, resin

Zapalign Inc. (Anyang-si Gyeonggi): 20 new FDA device listings, incl. agent, tooth bonding, resin. Its amount of 20 is top-decile (97th percentile of 2,570 records). Dated 49 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 20 · 97th percentile of 2,570 DeviceEstablishmentPulse records · 20.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 116 related KR DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentZapalign Inc.
RoleForeign exporter
Establishment typesExport Device to the United States But Perform No Other Operation on Device
LocationAnyang-si Gyeonggi, KR
New listings20
DevicesAgent, Tooth Bonding, Resin; Material, Impression; Cement, Dental; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Bur, Surgical, General & Plastic Surgery; System, Skin Closure; Sealant, Pit And Fissure, And Conditioner; Zinc Oxide Eugenol; Set, Administration, Intravascular
Product codesKLE, ELW, EMA, EBF, EBG, GFF, MKY, EBC, EMB, FPA, ELZ
Device classesClass I, Class II
Medical specialtiesDental, General, Plastic Surgery, General Hospital
Brand namesAGENT, TOOTH BONDING, RESIN; MATERIAL, IMPRESSION; CEMENT, DENTAL; Material, tooth shade, resin; CROWN AND BRIDGE, TEMPORARY, RESIN; BUR, SURGICAL, GENERAL & PLASTIC SURGERY; SYSTEM, SKIN CLOSURE; ZINC OXIDE EUGENOL
First new listing2026-05-04
Latest new listing2026-09-16
FDA registration number3011944170
Registration expires2026-12-31
amount percentile97th of 2,570 (median 1, 20.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-09-16
  • Data refreshed: 2026-10-28
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Zapalign Inc. and 117 KR peers

  • KR DeviceEstablishmentPulse records like this one: 117
  • Zapalign Inc.'s amount: 97th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every KR peer: $23,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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55 / 100 Score

  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.

What is the DeviceEstablishmentPulse record for Zapalign Inc. in Anyang-si Gyeonggi?

Zapalign Inc. (Anyang-si Gyeonggi, KR), a foreign exporter, added 20 FDA device listings between 2026-05-04 and 2026-09-16.

How does Zapalign Inc. compare to other DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 20 is 20.0x the median of 1 across 2,570 records. It is 49 days old; check the official source for later updates before acting.

Zapalign Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Zapalign Inc.Anyang-si Gyeonggi, KR2097th2026-09-16
Makar Consulting PTY LtdBelrose New South Wales, AU2197th2026-10-16
Tam Viet Distribution Company LimitedHo Chi Minh, VN1796th2026-10-16
Kash Sales Inc.Richmond Hill Ontario, CA1596th2026-10-16

Related records

DeviceEstablishmentPulse: Foreign exporter DeviceEstablishmentPulse: Foreign establishment

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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